Guaifenesin

Product NDC
30142-962
11-digit product format
301420962
Labeler code
30142
Product ID
30142-962_7b7122bb-375b-4a86-a494-1dd8995083a9
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Kroger Company
Application
ANDA209254
Marketing category
ANDA
Marketing start
2022-04-20
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin
Brand name suffix
Extended Release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii495W7451VQ
Rxcui310621

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-962-14Guaifenesin Extended Release14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE142
30142-962-14Guaifenesin Extended Release1 in 1 CARTONTABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-962GUAIFENESIN EXTENDED RELEASE (GUAIFENESIN) TABLET, EXTENDED RELEASE [KROGER COMPANY]2Current NDC, Legacy NDC, 2 package rows20220422_d434656a-221b-40fc-81ad-2b698be1aa33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSNd434656a-221b-40fc-81ad-2b698be1aa332
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCDd434656a-221b-40fc-81ad-2b698be1aa332
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSYd434656a-221b-40fc-81ad-2b698be1aa332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-962-14301420962141 BLISTER PACK in 1 CARTON (30142-962-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2022-04-200000-00-00NoNoCurrent